WASHINGTON – An Oregon man stopped taking the painkiller Vioxx when it was pulled from the market, switching to Bextra. Then questions were raised about Bextra – and four other drugs – and he returned to his doctor with a new set of worries.

Similar conversations are happening between doctors and patients all around the country.

In testimony Thursday before the Senate Finance Committee, Food and Drug Administration drug safety reviewer David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent as unsafe.

Drug makers defended the safety of their products and one of Graham’s bosses at the FDA derided his comments as “wildly exaggerated, inaccurate, baseless statements.”

Patients – uncertain whether to believe the FDA or one of its own safety reviewers – are pressing their own doctors for guidance.

A majority of patients in Dr. Elizabeth A. Tindall’s practice in Portland suffer from rheumatoid arthritis and osteoarthritis, like the patient who switched painkillers from Vioxx to Bextra. The 50-something man is thin and athletic, but has a family history of heart disease.

“He had tons of questions, 25 minutes of questions,” Tindall said.

Ultimately, because Bextra hasn’t been scrutinized as intently as Vioxx and the man’s stomach doesn’t bother him, he’ll try an older anti-inflammatory.

Tindall expects another volley of questions once Graham’s testimony makes the rounds on news shows.

“After Vioxx, it was unbelievable the number of phone calls and questions and anxiety level that patients had. It was very, very scary,” she said.

Dr. Eric Lang, a geriatric internist in Philadelphia, prescribes Bextra, Crestor and Serevent.

Four months ago, when safety concerns flared for the anti-cholesterol drug, he stopped prescribing Crestor and called patients to tell them not to take it. After doing more research, four months ago he put 100 of his patients back on the drug.

On Friday, nearly three dozen called with questions about Crestor.

“They basically are worried about the safety aspect,” Lang said. “There’s no question as to whether it’s effective. But they’re concerned: How safe is it and if they should be switched to other medications or taken off completely?”

Lang told his patients on Crestor to “stay the course.”

Patricia Dorazio, 67, who lives outside of Philadelphia, made that choice on her own. Dorazio has suffered from severe headaches since age 18. Until Bextra, no drug eased the debilitating pain that forced her to cancel appointments and remain in bed all day.

“I can live a normal life and, to me, that is such a plus,” she said.

Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, derided Graham’s statements as “wildly exaggerated” and called his research methods “junk science.”

Graham told the Congressional panel that he pushed for a dozen drugs to be withdrawn. Of that list, only the acne drug Accutane and the arthritis drug Arava remain on the market.

Graham blasted the FDA as an agency so flawed that it left the nation “virtually defenseless” against the next Vioxx debacle.

With such dramatically different viewpoints, whom should a consumer believe?

Consumer advocate Sidney Wolfe pointed to testimony by Dr. Sandra Kweder, acting director of FDA’s Office of New Drugs, that too much focus was placed on the risk of drugs without considering medications’ benefits.

“If there’s a problem in the FDA, it’s that they’re focusing too much on the benefits and not enough on the risks,” said Wolfe, director of Public Citizen. “The way the FDA is functioning now is not something that lends a lot of basis for trust.”



On the Net:

FDA: http://www.fda.gov/

AP-ES-11-19-04 1718EST



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